Comparing proton and photon therapy for IDH-mutated gliomas
PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
This study tests whether proton therapy can be as effective as traditional photon therapy for people with certain types of brain tumors while possibly improving their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05190172 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of proton therapy compared to traditional photon therapy in patients with IDH-mutated grade II and III diffuse gliomas. It aims to determine if proton therapy can achieve similar survival rates while potentially improving quality of life and reducing rehabilitation needs. Patients aged 18 to 65 with a confirmed diagnosis will be randomized to receive either treatment, and their outcomes will be assessed over a two-year period. The study will also include neuropsychological testing to evaluate cognitive abilities post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with IDH-mutated grade II or III diffuse gliomas who require radiotherapy.
Not a fit: Patients with significant contrast-enhancing tumors or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could establish proton therapy as a safer and more effective treatment option for patients with IDH-mutated diffuse gliomas.
How similar studies have performed: While proton therapy has shown promise in other contexts, this specific comparison with photon therapy in IDH-mutated gliomas is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
1. Patients must be 18 to 65 years old on the day of consent. 2. IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021. 3. Indication for radiotherapy. 4. WHO/ECOG performance status 0-2. 5. Ability to undergo MRI. 6. No significant contrast enhancing tumour (more than 1 or 2 punctate contrast enhancing foci) at the time of randomization. In recurrence patients, no contrast enhancement is allowed unless a new biopsy confirms the diagnosis of IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3. 7. Ability and willingness to travel to a proton therapy centre if randomized to the proton therapy arm. 8. Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception during radiotherapy, chemotherapy and 1 year after completion of chemotherapy. Pregnancy is not an ineligibility criterium if radiotherapy is indicated and cannot be postponed 9. Ability to understand the information about the study and included treatment. 10. Signed informed consent. 11. Ability to speak and understand Norwegian or Swedish language. Exclusion Criteria: 1. Prior treatment (except surgery) for diffuse glioma 2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years 3. Known CDKN2A/B homozygous deletion 4. Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study protocol procedures including follow-up 5. Body weight \> 150 kg
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Petter Brandal, MD PhD — Head of Neurooncology
- Study coordinator: Petter Brandal, MD PhD
- Email: petter.brandal@ous-hf.no
- Phone: +47 22934000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.